The following data is part of a premarket notification filed by Dade Chemistry Systems, Inc. with the FDA for Human Chorionic Gonadotropin Calibrator.
| Device ID | K970396 |
| 510k Number | K970396 |
| Device Name: | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR |
| Classification | Calibrator, Surrogate |
| Applicant | DADE CHEMISTRY SYSTEMS, INC. RT. 896, GLASCOW BLDG. 500 Glasgow, DE 19702 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE CHEMISTRY SYSTEMS, INC. RT. 896, GLASCOW BLDG. 500 Glasgow, DE 19702 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013737 | K970396 | 000 |